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COURAGE TRIAL |
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|---|---|
| Problem | Stable CAD |
| Format | Multi-center RCT |
| Treatment | PCI |
| Control | Optimal medical therapy |
| Population | 2287 patients |
| Inclusion criteria | Stable CAD or Canadian Cardiovascular Society (CCS) class IV angina subsequently stabilized medically Stenosis of at least 70% in at least one proximal coronary artery Objective evidence of myocardial ischaemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress) or at least one coronary stenosis of at least 80% and classic angina without provocative testing. |
| Exclusion criteria | Persistent CCS class IV angina Markedly positive stress test (substantial ST-segment depression or hypotensive response during stage 1 of the Bruce protocol) Refractory heart failure or cardiogenic shock An ejection fraction of less than 30% Revascularization within the previous 6 months Coronary anatomy not suitable for PCI. |
| Follow-up | Median 4.6 years |
| Primary endpoint | Composite of death from any cause and nonfatal myocardial infarction |
| Secondary endpoint(s) | Composite of death, myocardial infarction, and stroke Hospitalization for unstable angina with negative biomarkers |
| Details | For OMT, all patients received aspirin (81–325 mg/day) or clopidogrel (75 mg/day). All patients received simvastatin alone or in combination with ezetimibe to reduce LDL-cholesterol levels (target of 1.55–2.220 mmol/L). Exercise, fibrates and/or extended release niacin were used to raise HDL-cholesterol levels (target 1.03 mmol/L) and to reduce triglyceride levels (target of 1.69 mmol/L). Both groups received anti-ischemic therapy (metoprolol, amlodipine and/or isosorbide mononitrate) with lisinopril or losartan. |
| Brief summary: | PCI w/ bare-metal stents in stable CAD non-superior to medical therapy |
| PAPER: Optimal medical therapy with or without PCI for stable coronary disease. | |
|---|---|
| Date | 12 Apr 2007 |
| Journal | N Engl J Med. 2007 Apr 12;356(15):1503-16. |
| Information | PCI (with BMS) vs. medical therapy in stable CAD -No difference in composite of all-cause mortality and non-fatal MI -No difference in ACS hospitalisation |
| PAPER: Effect of PCI on quality of life in patients with stable coronary disease. | |
|---|---|
| Date | 14 Aug 2008 |
| Journal | N Engl J Med. 2008 Aug 14;359(7):677-87. |
| Information | PCI vs. medical therapy -At 3 months --53% in PCI group angina-free vs. 42% medical-therapy (P<0.001) -Benefit observed until 24 months -No significant difference at 36 months --Likely represents progression of CAD |
| PAPER: Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients. | |
|---|---|
| Date | 1 Sep 2008 |
| Journal | Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):12-20. |
| Information | Cost-effectiveness analysis for PCI vs. medical therapy in stable CAD -Cost ~$10,000, without significant gain in life-years or quality-adjusted life-years -$168,000-$300,000 per QALY |